MAUDE Adverse Event Report: CRAFTMATIC INDUSTRIES CRAFTMATIC MODEL 1 BASE; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number M1242

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Fall (1848)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

Unique id#: (b)(4).Reordered a 39x74 dual density mattress, order number: (b)(4); spoke to (b)(6).Customer confirmed that the mattress has been delivered 10/30/20.No further assistance is required.Based on the information provided by the customer; the complaint is reportable per cfr 21 803.3.Craftmatic is presently in the process of obtaining a udi.

Event Description

On 10/5/20, at 1:24 pm, (b)(6), states she received the wrong mattress upon delivery.She states she sat at the foot of the mattress and it moved, the customer states the mattress is longer and narrower than the base.The customer recently moved, and did not have a bed prior to the delivery of her new bed.The customer claims she has fallen at least five times already.She states she sleeps against the wall, but when she rolls over, she falls out of bed.Customer states she does not have require assistance entering or exiting the bed and has no mobility issues.She states she hit her head and hip but did not seek medical treatment.She is(b)(6), and weighs about (b)(6) pounds.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES; 3580 gateway drive; pompano beach FL 33069
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES; 3580 gateway drive; pompano beach FL 33069
• Manufacturer Contact: jessica vivar ; 3580 gateway drive; pompano beach, FL 33069 ; 9548280893
• MDR Report Key: 10836160
• MDR Text Key: 216946361
• Report Number: 3008872045-2020-00010
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M1242
• Device Catalogue Number: CMMOD1
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 91